A Study to Evaluate the Effects of Manidipine Versus Amlodipine and the Combination of Manidipine Plus Delapril Versus Amlodipine Plus Delapril on Intraglomerular Pressure in Hypertensive Patients

• ClinicalTrials.gov Identifier: NCT00627952
• Recruitment Status: Completed
• First Posted: March 4, 2008
• Last Update Posted: January 21, 2013
• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborator: Chiesi Farmaceutici S.p.A.
• Information provided by (Responsible Party): Roland E. Schmieder, University of Erlangen-Nürnberg Medical School

Tracking Information

• First Submitted Date: February 24, 2008
• First Posted Date: March 4, 2008
• Last Update Posted Date: January 21, 2013
• Study Start Date: November 2007
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 24, 2008): effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure [ Time Frame: 4 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: February 24, 2008): effects of combination of manidipine 10 mg plus delapril 30 mg once daily compared with once daily amlodipine 5 mg plus delapril 30 mg on intraglomerular pressure [ Time Frame: 4 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Effects of Manidipine Versus Amlodipine and the Combination of Manidipine Plus Delapril Versus Amlodipine Plus Delapril on Intraglomerular Pressure in Hypertensive Patients
• Official Title: Double Blind, Randomized, Parallel Group, Multicentre Study to Evaluate the Effects of Manidipine 20 MG Vs. Amlodipine 10 MG and the Combination of Manidipine 10 MG Plus Delapril 30 MG Vs. Amlodipine 5 MG Plus Delapril 30 MG on Intraglomerular Pressure in Hypertensive Patients
• Brief Summary: Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase.
• Detailed Description: The aim of the current study is to assess the effect of a 4-week single drug treatment with manidipine or amlodipine and a 4-week combination treatment with manidipine plus delapril or amlodipine plus delapril on intraglomerular pressure in subjects with hypertension.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• Drug: amlodipine 10 mg
  amlodipine 10 mg once daily
• Drug: manidipine 20 mg
  manidipine 20 mg once daily
• Drug: amlodipine 5 mg + delapril 30 mg
  amlodipine 5 mg + delapril 30 mg once daily
• Drug: manidipine 10 mg + delapril 30 mg
  manidipine 10 mg + delapril 30 mg once daily

Study Arms

• Active Comparator: amlodipine 10 mg
  Interventions:

  • Drug: amlodipine 10 mg
  • Drug: amlodipine 5 mg + delapril 30 mg
• Active Comparator: manidipine 20 mg
  Interventions:

  • Drug: manidipine 20 mg
  • Drug: manidipine 10 mg + delapril 30 mg

• Publications *: Bosch AJ, Harazny JM, Kistner I, Friedrich S, Wojtkiewicz J, Schmieder RE. Retinal capillary rarefaction in patients with untreated mild-moderate hypertension. BMC Cardiovasc Disord. 2017 Dec 21;17(1):300. doi: 10.1186/s12872-017-0732-x.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 24, 2008): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• male or female patients aged 18 years or older
• mild to moderate hypertension (systolic blood pressure > 139 mmHg or diastolic blood pressure > 89 mmHg)

Exclusion Criteria:

• secondary form of arterial hypertension
• severe hypertension (systolic blood pressure > 179 mmHg or diastolic blood pressure > 109 mmHg)
• pregnant or lactating women

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00627952
• Other Study ID Numbers: 2006-006350-10; MANTRA
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
• Original Responsible Party: Prof. Roland E. Schmieder, Clinical Research Center, Department of Nephrology and Hyperension, University of Erlangen-Nuremberg
• Current Study Sponsor: University of Erlangen-Nürnberg Medical School
• Original Study Sponsor: University of Erlangen-Nürnberg
• Collaborators: Chiesi Farmaceutici S.p.A.

Investigators

• Principal Investigator: Roland E Schmieder, Professor; University of Erlangen-Nürnberg

• PRS Account: University of Erlangen-Nürnberg Medical School
• Verification Date: January 2013